<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20191231045968N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-20</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>The effect of curcumin supplementation plus resistance training in treatment of patients with Parkinson's</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of the effect of curcumin supplementation plus resistance training  compared with the placebo on disease severity and metabolic profiles in patients with Parkinson's</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45058</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Other design features: The patients and researchers have direct connection in order to performing the exercises thus, this study is not blinded. This work is a open labeled study, Randomization description: At study baseline, participants based on balanced blocked randomization will be allocated into four groups to take either curcumin supplementation plus resistance training (n=10), curcumin supplementation (n = 10), resistance training (n=10) or placebo (n = 10). Randomization will be done by the use of computer-generated random numbers.</study_design>
      <phase>3</phase>
      <hc_freetext>Parkinson disease.</hc_freetext>
      <i_freetext>Intervention 1: 500 mg curcumin capsule ( contain 450 mg turmeric powder and 50 mg tumeric concentration equivalent with 47.5 mg curcumin) twice a day, for 8 weeks. Exercises are designed in format of 3 circles in each session. The main exercise will be designed with variable intensity suitable with person's ability. The equipment includes leg extension and flexion machine, under hand cable pull down, chest press, shoulder press, elbow extension and flexion machine. The exercises are designed for 3 times per week ( 60 min for each time) for 8 weeks. Intervention 2: Intervention group: Resistance training (three times a week) for 8 weeks. Intervention 3: Intervention group: 500 mg curcumin capsule twice a day plus resistance training (three times a week) for 8 weeks. Intervention 4: Control group: Without resistance training and the consumption of curcumin supplementation.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pejman Motamedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Mofatteh Avenue, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1571914911</zip>
        <telephone>+98 26 3451 2001</telephone>
        <email>Pezhman.Motamedi@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Pejman Motamedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Mofatteh Avenue, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1571914911</zip>
        <telephone>+98 26 3451 2001</telephone>
        <email>Pezhman.Motamedi@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with Parkinson's
Aged 50 to 80 years</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking antioxidants supplements
Taking anti-inflammatory supplements
Depression
Severe psychosis
hypo- and hyperthyroidism
Smoking
Consuming curcumin supplements within 3 month prior to the study
Restrictions to practicing exercise, including cardiovascular disease, stroke, respiratory problems and any surgical procedures for the treatment of PD e.g.,  deep brain stimulation (DBS).
Motor deficits that could limit performance in exercise in the study
Practicing any regular physical activity except for resistance training in the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Parkinson's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>500 mg curcumin capsule ( contain 450 mg turmeric powder and 50 mg tumeric concentration equivalent with 47.5 mg curcumin) twice a day, for 8 weeks. Exercises are designed in format of 3 circles in each session. The main exercise will be designed with variable intensity suitable with person's ability. The equipment includes leg extension and flexion machine, under hand cable pull down, chest press, shoulder press, elbow extension and flexion machine. The exercises are designed for 3 times per week ( 60 min for each time) for 8 weeks.</i_keyword>
      <i_keyword>Intervention group: Resistance training (three times a week) for 8 weeks.</i_keyword>
      <i_keyword>Intervention group: 500 mg curcumin capsule twice a day plus resistance training (three times a week) for 8 weeks.</i_keyword>
      <i_keyword>Control group: Without resistance training and the consumption of curcumin supplementation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Unified Parkinson's disease rating scale. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Physical Examination by Neurologist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Insulin. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: ELISA kit.</sec_outcome>
      <sec_outcome>Insulin resistance. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Calculation using HOMA formula.</sec_outcome>
      <sec_outcome>Triglycerides. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Total cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>HDL-cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>LDL-cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Malondialdehyde. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Glutathione. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Total antioxidant capacity. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-03</approval_date>
        <contact_name>Ethics committee of Kharazmi University</contact_name>
        <contact_address>Kharazmi University, South Moffateh st, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
